The Senior Scientist, Toxicology reports to the Head of Nonclinical Development and serves as an integral contributor to all the nonclinical development projects at Epizyme. The Senior Scientist provides expertise and advice to guide the activities of a project, and provides scientific/technical expertise. Viewed as expert in the field within the department. Accountable for the development and implementation of solutions to problems. May develop new approaches and applications of programs and systems to lead processes in a new direction. Works independently toward goals and objectives of the department.

Responsibilities

• Execution of nonclinical safety evaluations to further drug discovery and development objectives
• Develop, and execute nonclinical safety development plans from discovery through late stage clinical development programs
• Participation on discovery and development teams
• Communication and collaboration with program teams and across functions (e.g. Biology, Clinical, DMPK, Medicinal Chemistry, CMC, etc.) to allow successful management of toxicology plans
• Frequent contacts with functional area leads and outside collaborators. Represents toxicology group in providing solutions to difficult technical issues associated with specific projects.
• Provide strategic advice for drug development programs
• Preparation of nonclinical safety assessment portions of regulatory documents
• Manage toxicology contract research organizations (CROs): i.e. selection, evaluations, timelines, communication, monitoring and budget
• Design toxicology study protocols, monitor and review studies conducted at CROs, provide integrated data evaluation and interpretation
• Communicate nonclinical safety data with the proper perspective to appropriate team and management forums within Epizyme and to external partners, as appropriate

Requirements

• MS/PhD in toxicology or related field with a minimum 5-7 years’ industry experience, Strong scientific background in pharmacology and toxicology, In depth knowledge of nonclinical drug development and regulatory requirements
• Strong organizational skills, ability to multi-task, flexible to change
• Superior communication skills (both written and oral), attention to detail, and good questioning and analysis techniques desired
• Demonstrated ability to continually expand knowledge base and open to learning from
  others
• Goal oriented, highly self-motivated and self-directing individual who enjoys working in different environments and multiple capacities
• Demonstrated ability to work collaboratively with various functional areas
• Experience with contracting CRO studies and effective communication with CROs to enable a quality working relationship, resulting in a quality product/report
• Must work effectively in a team environment and with individuals at all levels within an organization
• Experienced in preparation and review of regulatory documents
• Some travel required